Low-Protein Diet With Low-Protein Foods Versus a LPD Without LP Foods in Patients With Chronic Kidney Disease (CKD)

Randomized Controlled Trial of a Low-Protein Diet (LPD) With Low-Protein (LP) Foods Versus a LPD Without LP Foods in Patients With Chronic Kidney Disease (CKD): Efficacy and Feasibility Study

The KDOQI 2020 - Clinical practice guideline for nutrition in chronic kidney disease (CKD) -recommends protein restriction to reduce the risk of end-stage renal disease/death and improve quality of life, a low protein diet providing 0.55-0.60g dietary protein/ kg body weight/day is recommended. FLAVIS® is a product line of hypoprotein foods specially developed for the treatment of CKD.The use of low-protein foods may facilitate the achievement of nutritional goals in terms of protein intake and help patients to follow a low-protein diet.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease Stage 5; Chronic Kidney Disease stage4; Chronic Kidney Disease Stage 3B; Chronic Kidney Disease Stage 3A
• Intervention / Treatment: Other: Consumption of FLAVIS

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Abbeville, France, 80100
    • Clinique sainte isabelle
  • Aix-en-Provence, France
    • Cabinet médical du Dr Magnant
  • Besançon, France
    • CHU Besançon
  • Bordeaux, France
    • Maison du Rein
  • Bordeaux, France
    • Polyclinique Bordeaux Nord Aquitaine
  • Chalon-sur-Saône, France
    • CH Chalon
  • Clermont-Ferrand, France
    • Chu Gabriel Montpied
  • Le Mans, France
    • CH Le Mans
  • Lyon, France
    • Hospices Civiles de Lyon
  • Lyon, France
    • Saint Joseph Saint Luc
  • Marseille, France
    • Hôpital la conception
  • Mâcon, France
    • CH Mâcon
  • Paris, France
    • APHP - Hôpital Necker
  • Paris, France
    • Tenon hospital -APHP
  • Romans-sur-Isère, France
    • Hôpital Drôme Nord
  • Strasbourg, France
    • Nouvel Hopital Civil
  • Vienne, France
    • Calydial
  • Villefranche-sur-Saône, France
    • Hôpital Nord-Ouest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• CKD patient stage 3a-5 (<60 ml/min/1.73 m² estimated by CKD-EPI formula) and not on dialysis,
• With a good nutritional status (i.e., absence of malnutrition according to albumin, pre-albumine, BMI and no clinical and paraclinical criteria of malnutrition),
• Above 1g protein/ kg bw (ideal body weight),
• LPD-naïve patient,
• Motivated to LPD introduction (ensure during screening phase patient willingness to modify diet habits with counselling accurate follow-up),
• Available to attend the visits planned by the protocol and able to complete the data collection documents (diet record and self-administered questionnaires),
• Subject affiliated to a health insurance system or is a beneficiary (art. L.1121-11, Code of Public Health, France),
• Having given their informed written consent regarding its participation to the protocol.

Exclusion Criteria:

• Patient for whom dialysis or transplantation is planned/expected within the next 12 months
• Known allergic reactions to the ingredients present in FLAVIS products (milk, eggs, soy, nut),
• Uncontrolled Diabetes (HbA1C >8.5%),
• Active cancer (including a 5 years remission period),
• Psychiatric disorders or inability to follow the protocol,
• Evidence of any active infectious or uncontrolled inflammatory diseases,
• Inability to provide blood samples (poor venous capital),
• Inability to perform correct 24-hours urine collection,
• Any change of the chronic medication within 1 month before screening,
• Presence of any significant medical finding or significant history such as uncontrolled systemic diseases that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator,
• Patient with an active implanted medical device
• Simultaneous participation in another clinical trial or subject still within the exclusion period of a previous clinical trial.
• Vulnerable subjects (art. L. 1121-5 à 8 et L. 1122-1-2, Code of Public Health, France) are also excluded from the clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: COMPARATOR; Follow-up of the CKD patient according to current practice i.e. low protein diet.
Experimental: FLAVIS; Follow-up of the CKD patient according to the current practice i.e. low protein diet with the addition of of low-protein products (FLAVIS).	Other: Consumption of FLAVIS; Patients of the FLAVIS group will recevied FLAVIS products in addition to their diet follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness in terms of protein intake of a LPD with LP foods (FLAVIS products) compared to standard products (LPD without consumption of LP foods)	Maroni formula : (Measurement of urea in urine + ([patient weight]*0.031))*6.25	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protein intake during the 12 months follow-up	Maroni formula: (Measurement of urea in urine + ([patient weight]*0.031))*6.25	1 month, 3 month, 6 month and 9 month
Dietary adherence	3-day dietary record correlated to a 24-hour urine collection	baseline, 1 month, 3 month, 6 month and 12 month
Dietary compliance for products under study	quantities consumed of FLAVIS products.	monthly up to 12 months
Effects of the LPD on weight	Weight in kg	baseline, 1 month, 3 month, 6 month and 12 month
Effects of the LPD on body composition: water	Water in litres	baseline, 1 month, 3 month, 6 month and 12 month
Effects of the LPD on body composition: muscles	Muscles in Kg	baseline, 1 month, 3 month, 6 month and 12 month
Effects of the LPD on body composition: body protein content	Body protein content in Kg	baseline, 1 month, 3 month, 6 month and 12 month
Effects of the LPD on Blood	Blood Chemistry	baseline, 1 month, 3 month, 6 month, 9 month and 12 month
Effects of the LPD on Urine	Urine Chemistry	baseline, 1 month, 3 month, 6 month, 9 month and 12 month
Patient quality of life	SF-36 questionnaire score which from 0 to 100	baseline, 3 month, 6 month and 12 month
Effects of the LPD on BMI	Weight and height will be combined to report BMI in kg/m^2.	baseline, 1 month, 3 month, 6 month and 12 month
Effects of the LPD on diabetic patient glycemic profile	Hb1Ac will be measured	Baseline, 6 month and 12 month
Incidence of Adverse Events [Safety of the LPD]	Questioning and a clinical examination, biological analyses review	1 month, 3 month, 6 month, 9 month and 12 month
Incidence of Adverse Events [Safety of the LPD]	4-points Likert scale	3 month, 6 month and 12 month
Patient satisfaction with LPD	Auto-questionnaire with numerical scales, closed-ended questions and Likert scales	3 month, 6 month and 12 month

Collaborators and Investigators

• Sponsor: Dr. Schär AG / SPA
• Collaborators: Slb Pharma
• Investigators: Study Director: Laetitia Koppe, Dr, HCL

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2022
• Primary Completion (Actual): July 24, 2026
• Study Completion (Actual): July 24, 2026

Study Registration Dates

• First Submitted: August 1, 2022
• First Submitted That Met QC Criteria: August 3, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Actual): August 17, 2026
• Last Update Submitted That Met QC Criteria: August 13, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: safety; compliance; effectiveness; low-protein diet; low-protein foods; FLAVIS
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Acceptance of Health Care; Renal Insufficiency, Chronic; Patient Compliance
• Other Study ID Numbers: EFFLAVIS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No